APPENDIX 7: VISIT TO ALLERGY THERAPEUTICS,
Members visiting Allergy Therapeutics were: Lord
Broers, Lord Colwyn, Baroness Finlay of Llandaff (Chairman), Lord
Rea, Earl of Selborne, Lord Taverne. In attendance: Miss Sarah
2 February 2007
The Committee was welcomed by Mr Keith Carter, Chief
Executive Officer. The company had previously traded under the
Bencard brand, and SmithKline Beecham, before a management buy-in
during 1998 had formed Allergy Therapeutics.
Mr Ray Keeling, Head of Supply Operations, outlined
the different types of products the business supplied. The company
produced a range of therapeutic medicines, provocation solutions,
skin prick and patch tests, but focussed mainly on specific immunotherapy.
He noted that although immunotherapy had largely been developed
in the United Kingdom, the NHS made very little use of the treatment.
Allergy Therapeutics therefore sold most of its products abroad.
In addition to standard products kept in stock, the company also
produced named-patient products, manufactured as a "semi-stock,"
to which three or four allergens could be added according to each
Dr Bev Lees, Head of Science, gave a brief overview
of the research and development program at Allergy Therapeutics.
The company had developed PollinexQuattro, an ultra-short course
of subcutaneous immunotherapy, to treat seasonal allergic rhinitis
with only four pre-seasonal injections over three weeks. It was
claimed that the adjuvants, 3-deacylated monophosphoryl lipid
A (MPL®) and L-tyrosine, within the product enabled
it to be effective within such a short course. Three formulations
of PollinexQuattro had been developed to treat rhinitis caused
by either grass, tree or ragweed pollens. The product was available
on a named-patient basis in Austria, Germany, Greece, Italy, Portugal,
Spain and the United Kingdom. However, it still awaited the results
of phase III clinical trials and the MHRA would then need to approve
it before it could be used routinely within the NHS. The company
also had other PollinexQuattro treatments on the market as named-patient
products, which were used to treat allergies to rarer substances
such as olives and plantain.
Mr Rick Poland, Production, Engineering and Technical
Manager, described the process of converting raw pollen into a
series of dilutions for immunotherapy treatments. Various pollens
were imported from around the world, and each had to obtain a
certificate of analysis before it could be used. This certificate
verified that the pollen was not contaminated and helped to ensure
that the treatment would be safe and effective.
The company referred to immunotherapy products as
"vaccines." This term was used because the treatments
modified the immune system. However, the treatments were therapeutic
vaccines (which aimed to suppress the immune response once a disease
had developed) rather than prophylactic vaccines (which induced
the immune system to prevent diseases occurring).
The Committee was given a tour of the Noon Building,
a new manufacturing facility which had opened in January 2007.
The licensed manufacturing facility could produce a range of sterilised
parenteral products, and the building also contained the inspection,
labelling, packaging and despatch operations. The Committee viewed
individual workstations where named-patient products were prepared.
Video surveillance and computer systems had been installed in
each station to monitor production of the treatments.
Dr Murray Skinner, Development Manager, described
how the development team devised and supported new and existing
products and practices used within the company. The team's work
included the validation of assays used in research, obtaining
scientific data to support the company's manufacturing processes,
and supporting trials to ensure that products met the standards
required of them.
Mr Carter noted that the majority of allergy treatments
used in the United Kingdom, such as antihistamines and corticosteroids,
only offered short-term relief from symptoms and worked during
the final stages of an allergic reaction. But immunotherapy modified
the immune system to interrupt the beginning of the allergic reaction
and could prevent the symptoms of allergic disease for many years.
Although initially expensive, it was thought that immunotherapy
could therefore save the NHS money in the long-term. Furthermore,
studies had suggested that the use of immunotherapy in rhinitis
patients could prevent the development of asthma, which could
produce a further saving in terms of treatment costs.
Mr Carter felt that immunotherapy was not used in
the United Kingdom as much as it could be, partly because it involved
long courses of injections, and partly because some clinicians
were fearful of adverse systemic reactions. The company had therefore
invested heavily in the development of PollinexQuattro because
it believed that the treatment could answer both of these problems,
and felt that in the future all specialists in secondary care
should be able to administer it. However, it would not be suitable
for use by GPs.